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Clinical Trials/NCT03065426
NCT03065426
Unknown
Not Applicable

Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology

North Dakota State University2 sites in 1 country144 target enrollmentMay 11, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weight Change, Body
Sponsor
North Dakota State University
Enrollment
144
Locations
2
Primary Endpoint
Weight trajectory
Last Updated
8 years ago

Overview

Brief Summary

This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. This approach will expand current knowledge by examining the combined impact of empirically supported behavioral and biological data in a large sample over time. Intensive measurement of problematic eating behaviors, mood, and compliance with diet and exercise regimens post-surgery will be analyzed in the context of lterations in parallel with, or in response to, changes observed in the gut microbiota. Identifying these post-surgical predictors of weight loss and comorbidity resolution will allow for the development of individualized interventions to optimize surgery-related outcomes.

Registry
clinicaltrials.gov
Start Date
May 11, 2017
End Date
September 2021
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kristine Steffen

Associate Professor

North Dakota State University

Eligibility Criteria

Inclusion Criteria

  • In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
  • Age 18-65, inclusive

Exclusion Criteria

  • Alcohol or substance use disorder in past year
  • Severe psychiatric disorder that may affect ability to complete the protocol
  • Regular tobacco use during the last year
  • Current medication taken routinely and known to impact factors that may affect the gut microbiome
  • Use of any oral or injectable antibiotic in the past month
  • Use of commercially available pre/pro biotic in the past month
  • History of significant disease/disorder that would be expected to impact the microbiome of the gut
  • Inability to engage in physical activity or dietary monitoring
  • Nonprescribed/illicit drug use
  • Pregnant or breastfeeding

Outcomes

Primary Outcomes

Weight trajectory

Time Frame: 24 months

Weight outcomes following bariatric surgery

Study Sites (2)

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